Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of this prospective study is to analyze the postoperative paresthesias experienced in patients who undergo bilateral sagittal split osteotomies (BSSO) using an ultrasonic saw, versus a reciprocating saw. Patients included in the study are ages 15-45 scheduled to undergo BSSO surgery at the University of California, San Francisco. One side of the patient's mandible will be instrumented with either the Stryker Sonopet ultrasonic saw or traditional reciprocating saw, while the other side will receive the remaining intervention (determined via randomization on the day of surgery). Patient paresthesias will then be analyzed on each side for 3 months postoperatively (at postoperative days: 1, 7, 14, 28, and 84). Sensory examinations will be carried out by blinded examiners using von Frey hairs and two point discrimination testing. Patients will also subjectively rate their sensation on each side. The results will then be analyzed to determine if patient paresthesias, including the severity and duration, differed depending on which instrument was used, the ultrasonic or reciprocating saw.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reciprocating saw | Placebo Comparator | The traditional surgical instrument used for cutting bilateral sagittal split osteotomies |
|
| Sonopet ultrasonic saw | Active Comparator | This instrument is being compared to the reciprocating saw |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sonopet ultrasonic saw | Device | Ultrasonic saw to be used on a randomized side of the mandible, reciprocating saw will be used on other side |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Hypoesthesia Experienced at 3months | Count of patient mandibles who exhibited **any** hypoesthesia at 3months post-operation (i.e. VFH does not equal 0.008g). VFH filaments measure the minimum weight which a dermatome in question can sense. In this study, the measurements were designed to have the following range: 0.008g, 0.02g, 0.04g, 0.07g, 0.16g, 0.4g, 0.6g, 1g, 1.4g, 2g, 4g, 6g, 8g, 10g, 15g, with 0.008g being no neurosensory deficit. Although 28 persons completed the study, only 21 patients presented for their 3 month followup time, which was defined as with-in 15 days of 90th day after operation. Therefore, the denominator for this outcome is 21, for each intervention arm. The numerator is the number of Left or Right chin areas that exhibited less than "normal" sensation. | Within 15 days of exact 3 months post-operation |
| Measure | Description | Time Frame |
|---|---|---|
| Unfavorable Fracture | When a saggital split osteotomy is performed, a controlled fracture of the mandibular ramus is induced which follows an exact intended path of fracture. An unfavorable fracture is one that does not follow this exact path of fracture, and needs to be surgically mended. An unfavorable fracture is associated with poorer post-operative recovery. | This outcome occurs during the surgery. It was measured on the same day. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sohail Saghezchi, DDS, MD | UC San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco Medical Center | San Francisco | California | 94143 | United States | ||
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Please note that since this is a pair-matched "split-mouth" study, where each participant was in both arms of the study since their left and right mandibles were the units receiving the different interventions in the study. Therefore, the total persons enrolled was 32 persons, while the total mandibles enrolled was 64.
| ID | Title | Description |
|---|---|---|
| FG000 | Reciprocating Saw | The traditional surgical instrument used for cutting bilateral sagittal split osteotomies Reciprocating saw: See above description |
| FG001 | Sonopet Ultrasonic Saw |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 30, 2025 |
Not provided
Not provided
A matched-pair (with-in person) RCT design will be used, wherein one mandibular side (right versus left) in each patient will be randomized to be treated with Sonopet ultrasonic device (with the remaining side being treated with reciprocating saw). Neurosensory impairment, as herein described, will be compared at various post-operative times for a total follow-up of 3 months for each patients. Patients and the researchers examining patients post-operatively will be blinded.
Not provided
Not provided
Patients and providers assessing postoperative nerve functioning are blinded to which side of the mandible received which intervention
| Reciprocating saw | Device | See above description |
|
| UCSF Benioff Children's Hospital |
| San Francisco |
| California |
| 94158 |
| United States |
This instrument is being compared to the reciprocating saw
Sonopet ultrasonic saw: Ultrasonic saw to be used on a randomized side of the mandible, reciprocating saw will be used on other side
|
| COMPLETED | Each study participant was assigned to both study arms, while only one of their two mandibular rami was assigned to that study arm. |
|
| NOT COMPLETED |
|
|
Each study participant was assigned to both study arms, while only one of their two mandibular rami was assigned to that study arm, and received that treatment. Since 4 persons were lost to followup, the baseline participants groups only contains 28 persons.
| ID | Title | Description |
|---|---|---|
| BG000 | Reciprocating Saw | The traditional surgical instrument used for cutting bilateral sagittal split osteotomies Reciprocating saw: See above description |
| BG001 | Sonopet Ultrasonic Saw | This instrument is being compared to the reciprocating saw Sonopet ultrasonic saw: Ultrasonic saw to be used on a randomized side of the mandible, reciprocating saw will be used on other side |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Mandibular Rami |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Please note that this is a "split-mouth" study, where each participant is enrolled in both arms of the study. | Mean | Standard Deviation | years | Participants |
| |||||||||||||
| Sex: Female, Male | Count of Participants | Participants | Participants |
| |||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants | Participants |
| |||||||||||||||
| Normal Baseline VFH Score (Lightest VFH Filament sensed has a weight of 0.008g) | VFH filaments are used to measure the lightest force sensed by a dermatome in question. In this study, the measurements range from: 0.008g, 0.02g, 0.04g, 0.07g, 0.16g, 0.4g, 0.6g, 1g, 1.4g, 2g, 4g, 6g, 8g, 10g, 15g. Someone who can sense the finest measurement of 0.008g is said to have no neurosensory deficit, hence a "Normal Baseline VFH Score". | Count of Units | Mandibular Rami | Mandibular Rami |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Postoperative Hypoesthesia Experienced at 3months | Count of patient mandibles who exhibited **any** hypoesthesia at 3months post-operation (i.e. VFH does not equal 0.008g). VFH filaments measure the minimum weight which a dermatome in question can sense. In this study, the measurements were designed to have the following range: 0.008g, 0.02g, 0.04g, 0.07g, 0.16g, 0.4g, 0.6g, 1g, 1.4g, 2g, 4g, 6g, 8g, 10g, 15g, with 0.008g being no neurosensory deficit. Although 28 persons completed the study, only 21 patients presented for their 3 month followup time, which was defined as with-in 15 days of 90th day after operation. Therefore, the denominator for this outcome is 21, for each intervention arm. The numerator is the number of Left or Right chin areas that exhibited less than "normal" sensation. | Although 28 persons completed the study, only 21 patients presented for their 3 month followup time, which was defined as with-in 15 days of 90th day after operation. | Posted | Count of Units | Left or Right Chin Area | Within 15 days of exact 3 months post-operation | Left or Right Chin Area | Left or Right Chin Area |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Unfavorable Fracture | When a saggital split osteotomy is performed, a controlled fracture of the mandibular ramus is induced which follows an exact intended path of fracture. An unfavorable fracture is one that does not follow this exact path of fracture, and needs to be surgically mended. An unfavorable fracture is associated with poorer post-operative recovery. | Each study participant was enrolled in both study arms, but only one of each person's two mandible was randomized to each study arm. | Posted | Count of Units | Mandibular rami | This outcome occurs during the surgery. It was measured on the same day. | Mandibular rami | Mandibular rami |
|
|
At a minimum each participant who was not lost to follow up was followed for three months (defined as 85 - 115 days) after their operation. However, patients were followed as long as they return for assessment of their orthognathic surgery. The follow up of participants who completed the study ranged from 85 days to 419 days.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Reciprocating Saw | The traditional surgical instrument used for cutting bilateral sagittal split osteotomies Reciprocating saw: See above description | 0 | 28 | 0 | 28 | 4 | 28 |
| EG001 | Sonopet Ultrasonic Saw | This instrument is being compared to the reciprocating saw Sonopet ultrasonic saw: Ultrasonic saw to be used on a randomized side of the mandible, reciprocating saw will be used on other side | 0 | 28 | 0 | 28 | 1 | 28 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Transaction of Inferior Alveolar Nerve (IAN), which provides sensation to the chin area | Surgical and medical procedures | Systematic Assessment | This study tested the effect of using two different kinds of cutting saws on neurosensory outcomes of the left or right chin areas. The sensation to this area is provided by the IAN, which is always at risk of being transacted during this surgery. |
|
Given the relatively few secondary outcome occurrences, unfavorable mandibular fractures, which occurred in 2/28 in the reciprocating saw arm and 0/28 in the ultrasonic saw arm, it is not possible to meaningfully interpret the findings for the secondary outcome.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sepehr Hashemi, DMD | University of Califronia, San Francisco | 4133674736 | sepehr.hashemi@ucsf.edu |
| May 31, 2025 |
| Prot_SAP_003.pdf |
Not provided
| ID | Term |
|---|---|
| D010292 | Paresthesia |
| D050723 | Fractures, Bone |
| D009408 | Nerve Compression Syndromes |
| D000080902 | Mandibular Nerve Injuries |
| D008844 | Micrognathism |
| D008313 | Malocclusion, Angle Class III |
| ID | Term |
|---|---|
| D020886 | Somatosensory Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D061221 | Trigeminal Nerve Injuries |
| D020433 | Trigeminal Nerve Diseases |
| D005156 | Facial Neuralgia |
| D005155 | Facial Nerve Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D020209 | Cranial Nerve Injuries |
| D003389 | Cranial Nerve Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D007569 | Jaw Abnormalities |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D019767 | Maxillofacial Abnormalities |
| D019465 | Craniofacial Abnormalities |
| D009139 | Musculoskeletal Abnormalities |
| D018640 | Stomatognathic System Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008310 | Malocclusion |
| D014076 | Tooth Diseases |
Not provided
Not provided
| Male |
|
| African American |
|
| Latinx |
|
| Asian |
|
|
| Mandibular rami |
|
|